The following data is part of a premarket notification filed by Magnivision, Inc. with the FDA for Confees(r)+ Contact Lens Holder.
Device ID | K897084 |
510k Number | K897084 |
Device Name: | CONFEES(R)+ CONTACT LENS HOLDER |
Classification | Case, Contact Lens |
Applicant | MAGNIVISION, INC. P.O. BOX 817 Miami, FL 33152 |
Contact | Roy Hirschfeld |
Correspondent | Roy Hirschfeld MAGNIVISION, INC. P.O. BOX 817 Miami, FL 33152 |
Product Code | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-20 |
Decision Date | 1990-02-28 |